drugset / Trial / NCT07213934

Phase I/ II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Recurrent Head and Neck Squamous Cell Carcinoma

NCT07213934

Phase 1/2 Recruiting 40 enrolled University of Cincinnati
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the Phase I study is to see if it is safe to use X-ray photon radiation (XRT) and proton radiation (PT) before surgery in patients with recurrent head and neck squamous cell carcinoma (rHNSCC). The purpose of the Phase II study is to see if using XRT or PT before immunotherapy (pembrolizumab) prior to surgery benefits patients with recurrent head and neck squamous cell carcinoma (rHNSCC).

Timeline

Start
2025-10-08
Primary completion
2030-12
Completion
2031-12

Drugs

EvaluationDrugModalityDoseRoute
Background Pembrolizumab Monoclonal antibody